Scientist – Process Development, Drug Substance Lifecycle

About the role

In this role, you will provide technical expertise and lifecycle support for biologics programs as they progress through development, validation, commercialization, and post-approval manufacturing. You'll collaborate across Manufacturing, Quality, MS&T, Regulatory, Project Management, and client teams to drive successful program execution and continuous process improvement.

About Catalent Madison

Catalent's Madison, Wisconsin facility is a state-of-the-art biologics development and manufacturing site supporting customers from research through early- and mid-stage clinical production. Located at 726 Heartland Trail, the 102,700-square-foot GMP facility specializes in mammalian cell line engineering, drug substance manufacturing, and biopharmaceutical process development. The site is home to Catalent's proprietary GPEx® and GPEx® Lightning technologies, enabling the generation of high-producing mammalian cell lines for biologic therapies. With production capabilities ranging from 50L to 4,000L and a recent $45 million expansion, the Madison campus continues to play a critical role in Catalent's global biologics network while supporting Wisconsin's growing life sciences industry.

Responsibilities

• Lead process characterization activities for development, validation, and commercial-stage biologics programs.
• Support process validation, continued process verification, comparability assessments, and lifecycle change management.
• Analyze process performance data, identify improvement opportunities, and drive risk reduction initiatives.
• Serve as a technical subject matter expert for assigned programs and client interactions.
• Author and review technical protocols, reports, validation documents, and regulatory support documentation.
• Support investigations, CAPAs, change controls, and quality system activities in a cGMP environment.
• Collaborate with cross-functional teams to ensure successful technology transfer and commercial manufacturing support.
• Other responsibilities as needed.

Required Qualifications

• PhD in a STEM discipline or Master's degree with a minimum of 3 years of relevant industry experience; or Bachelor's degree with a minimum of 6 years of relevant industry experience.

Preferred Qualifications

• Experience supporting biologics development, characterization, validation, or commercial manufacturing.
• Knowledge of process characterization, PPQ, lifecycle management, and validation principles.
• Experience working within cGMP environments.
• Familiarity with statistical analysis tools such as JMP, Minitab, or Excel.
• Experience supporting cross-functional technical projects and client-facing activities.

Benefits

• Competitive compensation package, including incentive opportunity.
• Day-one medical, dental, and vision coverage.
• 401(k) with company match.
• Tuition reimbursement and professional development opportunities.
• Generous paid time off and holiday schedule (152 hours + 8 holidays).
• Collaborative, mission-driven culture focused on improving patient outcomes worldwide.